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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Citalopram Hydrobromide in Postmenopausal Women With Hot Flashes

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI	NCCTG-N05C9 NCT00363909

Trial Description

Purpose:

Citalopram may help relieve hot flashes in women who had or have not had breast cancer. It is not yet known which dose of citalopram is more effective in treating hot flashes in postmenopausal women.

This randomized phase III trial is studying three different doses of citalopram to compare how well they work in treating postmenopausal women with hot flashes.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has had breast cancer but is currently cancer free or no previous breast cancer and unwilling to take estrogen replacement therapy
• Has at least 14 hot flashes each week for at least the past month
• At least 4 weeks since chemotherapy for cancer or hormone therapy
• At least 3 months since antidepressants
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of four treatment groups.

Patients in group one will receive one tablet of citalopram by mouth once a day for 6 weeks.

Patients in group two will receive one tablet of citalopram by mouth once a day for 1 week and two tablets once a day for 5 weeks.

Patients in group three will receive one tablet of citalopram by mouth once a day for 1 week, two tablets once a day for 1 week, and 3 tablets once a day for 4 weeks.

Patients in group four will receive a placebo by mouth one to three times a day for 6 weeks.

Patients will complete a 7-week diary of their hot flashes and symptoms. They will also complete questionnaires before beginning treatment and at week 7.

All patients will undergo blood sample collection periodically during treatment.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Debra Barton, RN, PhD, AOCN, FAAN, Study coordinator		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Beth La Vasseur, RN, MS, Study coordinator		Ph: 734-712-5658; 888-474-4673 Email: lavasseb@trinity-health.org
Charles Loprinzi, MD, Study coordinator		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes
Trial Start Date		2006-11-03
Registered in ClinicalTrials.gov		NCT00363909
Date Submitted to PDQ		2006-06-06
Information Last Verified		2007-04-13
NCI Grant/Contract Number		CA37404

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